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Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

Primary Purpose

Cancer Debulking, Enlarged Uterus, Fibroid Uterus

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Morphine
Lidocaine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Debulking focused on measuring ERAS, Multi-modal anesthesia, Opioid consumption, Intrathecal, Epidural, Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients ≥18 years old
  • Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
  • No clinical or laboratory evidence of end organ failure:

If available:

  • Platelets > 100 K/cumm
  • Hemoglobin > 8.0 g/dl
  • Serum creatinine <1.5 mg/dl
  • Creatine clearance (CrCl) ≥30 based on the original Cockcroft-Gault formula adjusted for weight.
  • INR <1.3 reference range
  • All other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value.

Exclusion Criteria:

  • Patients not giving consent to participate in the study
  • Unable to complete self-report pain questionnaire
  • Moderate to severe kidney or liver failure per lab criteria as outlined
  • Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines
  • Contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection
  • Complete bowel obstruction
  • Contraindication to intravenous lidocaine
  • No known pregnancy and not lactating.
  • Currently septic
  • Patient currently taking more than 30 MME a day preoperatively (for >30 days)
  • BMI >50kg/m2
  • Intolerance or contraindication to receiving non-steroidal anti-inflammatory drugs or acetaminophen

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)

Intrathecal morphine with intraoperative lidocaine infusion

Arm Description

Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol. Intraoperative: dexamethasone and epidural bupivacaine Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine Postoperative: hydromorphone PCA, ibuprofen, oxycodone

Day or surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg) Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight Day of surgery postoperative: toradol, ibuprofen, tylenol Postoperative: ibuprofen, oxycodone, and hydromorphone prn

Outcomes

Primary Outcome Measures

Morphine milligram equivalent (MME) in the postoperative hospital course

Secondary Outcome Measures

Rate of postoperative ileus
-Defined by bilious emesis requiring a change in diet to nothing-per-mouth (NPO) status or nasogastric tube placement (NGT) in the absence of other indications. Patients who had NGT placed prophylactically at the time of surgery were not considered to have an ileus unless an NGT was reinserted or they met the above criteria. Participants will be assigned a value of yes ileus or no ileus. The rate of post op ileus is defined as the observed number of yes ileus in each study arm divided by the total number of subjects in the study arm. Fisher's exact test will be used to compare non-paired nominal data.
Length of hospital stay
-Length of stay will be determined by the dates of admission as recorded on EPIC (days).
Rate of postoperative hypotension
-Postoperative hypotension will be defined as <90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.
Patient satisfaction with pain control
-Patients will be asked on day of discharge if they were satisfied with their pain control during their hospitalization. They will be able to choose from the following: 0=satisfied, 1= somewhat satisfied, 2= neutral, 3=somewhat dissatisfied, 4=dissatisfied).
Change in pain scores
-Pain scores will be determined by the 0-10 numeric rating scale (NRS). 0=no pain and 10=the most pain.
30 day readmission rate
Rate of deep vein thrombosis (DVT)
Rate of pulmonary thromboembolism (PTE)
Rate of persistent pain
-As determined by an NRS pain score ≥ 5

Full Information

First Posted
August 16, 2021
Last Updated
June 13, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05017246
Brief Title
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
Official Title
A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
Keywords
ERAS, Multi-modal anesthesia, Opioid consumption, Intrathecal, Epidural, Ileus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)
Arm Type
Active Comparator
Arm Description
Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol. Intraoperative: dexamethasone and epidural bupivacaine Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine Postoperative: hydromorphone PCA, ibuprofen, oxycodone
Arm Title
Intrathecal morphine with intraoperative lidocaine infusion
Arm Type
Experimental
Arm Description
Day or surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg) Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight Day of surgery postoperative: toradol, ibuprofen, tylenol Postoperative: ibuprofen, oxycodone, and hydromorphone prn
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Duramorph
Intervention Description
-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
-Lidocaine infusion 1 mg/kg ideal body weight (IBW)
Primary Outcome Measure Information:
Title
Morphine milligram equivalent (MME) in the postoperative hospital course
Time Frame
Postoperatively while patient is in hospital (estimated to be 4 days)
Secondary Outcome Measure Information:
Title
Rate of postoperative ileus
Description
-Defined by bilious emesis requiring a change in diet to nothing-per-mouth (NPO) status or nasogastric tube placement (NGT) in the absence of other indications. Patients who had NGT placed prophylactically at the time of surgery were not considered to have an ileus unless an NGT was reinserted or they met the above criteria. Participants will be assigned a value of yes ileus or no ileus. The rate of post op ileus is defined as the observed number of yes ileus in each study arm divided by the total number of subjects in the study arm. Fisher's exact test will be used to compare non-paired nominal data.
Time Frame
Postoperatively while patient is in hospital (estimated to be 4 days)
Title
Length of hospital stay
Description
-Length of stay will be determined by the dates of admission as recorded on EPIC (days).
Time Frame
Estimated to be 4 days
Title
Rate of postoperative hypotension
Description
-Postoperative hypotension will be defined as <90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.
Time Frame
Up to 48 hours after surgery
Title
Patient satisfaction with pain control
Description
-Patients will be asked on day of discharge if they were satisfied with their pain control during their hospitalization. They will be able to choose from the following: 0=satisfied, 1= somewhat satisfied, 2= neutral, 3=somewhat dissatisfied, 4=dissatisfied).
Time Frame
Day of hospital discharge (estimated to be day 4)
Title
Change in pain scores
Description
-Pain scores will be determined by the 0-10 numeric rating scale (NRS). 0=no pain and 10=the most pain.
Time Frame
Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up
Title
30 day readmission rate
Time Frame
Through day 30
Title
Rate of deep vein thrombosis (DVT)
Time Frame
From day of surgery (day 1) to 6 weeks after surgery
Title
Rate of pulmonary thromboembolism (PTE)
Time Frame
From day of surgery (day 1) to 6 weeks after surgery
Title
Rate of persistent pain
Description
-As determined by an NRS pain score ≥ 5
Time Frame
At 6 week follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients ≥18 years old Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service No clinical or laboratory evidence of end organ failure: If available: Platelets > 100 K/cumm Hemoglobin > 8.0 g/dl Serum creatinine <1.5 mg/dl Creatine clearance (CrCl) ≥30 based on the original Cockcroft-Gault formula adjusted for weight. INR <1.3 reference range All other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value. Exclusion Criteria: Patients not giving consent to participate in the study Unable to complete self-report pain questionnaire Moderate to severe kidney or liver failure per lab criteria as outlined Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines Contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection Complete bowel obstruction Contraindication to intravenous lidocaine No known pregnancy and not lactating. Currently septic Patient currently taking more than 30 MME a day preoperatively (for >30 days) BMI >50kg/m2 Intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Cohen, M.D.
Phone
314-362-3181
Email
cohenac@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Cohen, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Cohen, M.D.
Phone
314-362-3181
Email
cohenac@wustl.edu
First Name & Middle Initial & Last Name & Degree
Alexander Cohen, M.D.
First Name & Middle Initial & Last Name & Degree
Lindsay Kuroki, M.D., MSCI
First Name & Middle Initial & Last Name & Degree
Lara Crock, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

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